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The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

Primary Purpose

Aortic Insufficiency

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HAART 300 Annuloplasty Device
Sponsored by
Biostable Science & Engineering
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Insufficiency focused on measuring Aortic Insufficiency (AI) Aortic Regurgitation (AR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is 18 years of age or older
  • Subject has tri-leaflet aortic valve morphology

  • Subject has documented aortic valve disease which may or may not include:

    1. aortic valve insufficiency
    2. aortic root pathology
    3. pathology of the ascending aorta
    4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass
  • Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
  • Subject has reviewed and signed the written informed consent form
  • Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)

Exclusion Criteria:

  • The subject has pre-existing valve prosthesis in the aortic position
  • The subject's aortic valve morphology is not tri-leaflet
  • The subject has active endocarditis
  • Heavily calcified valves
  • The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
  • Leukopenia
  • Acute anemia (Hb < 9mg%)
  • Platelet count <100,000 cell/mm3
  • Need for emergency surgery for any reason
  • History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
  • Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
  • Subjects in whom transesophageal echocardiography (TEE) is contraindicated
  • Low Ejection Fraction (EF) EF < 35%
  • Life expectancy < 1 year
  • The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
  • The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
  • The subject is pregnant or lactating
  • Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  • Myocardial Infarction (MI) within one month of trial inclusion
  • The subject has a known intolerance to titanium or polyester
  • The subject has documented unstable or > 2 vessel coronary disease
  • The subject requires additional valve replacement or valve repair

Sites / Locations

  • Institute of Clinical and Experimental Medicine
  • German Heart Center
  • Klinik für Herz und Gefässchirurgie
  • Klinik und Poliklinik für Herz- und Gefäßchirurgie
  • Hannover Medical School (MHH)
  • Uniklinik Köln
  • Munchen Heart Center
  • Klinikum Nürnberg Süd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HAART 300 Annuloplasty Device

Arm Description

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Outcomes

Primary Outcome Measures

Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)

Secondary Outcome Measures

Implant Procedure Success
Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.
Actuarial Freedom From Clinical Cardiovascular Events
Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
Aortic Insufficiency (AI) at 2 Years
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area

Full Information

First Posted
November 20, 2012
Last Updated
January 30, 2017
Sponsor
Biostable Science & Engineering
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1. Study Identification

Unique Protocol Identification Number
NCT01732835
Brief Title
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
Official Title
The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biostable Science & Engineering

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.
Detailed Description
Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations. Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Insufficiency
Keywords
Aortic Insufficiency (AI) Aortic Regurgitation (AR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAART 300 Annuloplasty Device
Arm Type
Experimental
Arm Description
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Intervention Type
Device
Intervention Name(s)
HAART 300 Annuloplasty Device
Intervention Description
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Primary Outcome Measure Information:
Title
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
Time Frame
6 months
Title
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Description
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Implant Procedure Success
Description
Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.
Time Frame
discharge or 14 days postprocedure, whichever comes first
Title
Actuarial Freedom From Clinical Cardiovascular Events
Description
Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months
Time Frame
6 months
Title
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
Time Frame
2 years
Title
Aortic Insufficiency (AI) at 2 Years
Description
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time Frame
2 years
Title
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months
Description
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Time Frame
6 months
Title
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years
Description
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Time Frame
2 years
Title
Peak Gradient - Change From Baseline
Description
Transthoracic echocardiography parameter
Time Frame
Baseline and 6 months
Title
Peak Gradient - Change From Baseline
Description
Transthoracic echocardiography parameter
Time Frame
Baseline and 2 years
Title
Mean Gradient - Change From Baseline
Description
Transthoracic echocardiography parameter
Time Frame
Baseline and 6 months
Title
Mean Gradient - Change From Baseline
Description
Transthoracic echocardiography parameter
Time Frame
Baseline and 2 years
Title
LV Mass - Change From Baseline
Description
Left ventricular mass. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
LV Mass - Change From Baseline
Description
Left ventricular mass. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
LVID Diastole - Change From Baseline
Description
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
LVID Diastole - Change From Baseline
Description
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
LVID Systole - Change From Baseline
Description
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
LVID Systole - Change From Baseline
Description
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
LV Diastolic Volume - Change From Baseline
Description
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
LV Diastolic Volume - Change From Baseline
Description
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
LV Systolic Volume - Change From Baseline
Description
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
LV Systolic Volume - Change From Baseline
Description
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
LVEF - Change From Baseline
Description
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
LVEF - Change From Baseline
Description
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
Cardiac Output - Change From Baseline
Description
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time Frame
Baseline and 6 months
Title
Cardiac Output - Change From Baseline
Description
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time Frame
Baseline and 2 years
Title
Cardiac Index - Change From Baseline
Description
Hemodynamic parameter computed as cardiac output divided by body surface area
Time Frame
Baseline and 6 months
Title
Cardiac Index - Change From Baseline
Description
Hemodynamic parameter computed as cardiac output divided by body surface area
Time Frame
Baseline and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18 years of age or older Subject has tri-leaflet aortic valve morphology Subject has documented aortic valve disease which may or may not include: aortic valve insufficiency aortic root pathology pathology of the ascending aorta patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve Subject has reviewed and signed the written informed consent form Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable) Exclusion Criteria: The subject has pre-existing valve prosthesis in the aortic position The subject's aortic valve morphology is not tri-leaflet The subject has active endocarditis Heavily calcified valves The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis Leukopenia Acute anemia (Hb < 9mg%) Platelet count <100,000 cell/mm3 Need for emergency surgery for any reason History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics) Subjects in whom transesophageal echocardiography (TEE) is contraindicated Low Ejection Fraction (EF) EF < 35% Life expectancy < 1 year The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent The subject is pregnant or lactating Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA) Myocardial Infarction (MI) within one month of trial inclusion The subject has a known intolerance to titanium or polyester The subject has documented unstable or > 2 vessel coronary disease The subject requires additional valve replacement or valve repair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominico Mazzitelli, MD
Organizational Affiliation
Munchen Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Clinical and Experimental Medicine
City
Prague
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
German Heart Center
City
Berlin
ZIP/Postal Code
80636
Country
Germany
Facility Name
Klinik für Herz und Gefässchirurgie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinik und Poliklinik für Herz- und Gefäßchirurgie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Hannover Medical School (MHH)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Munchen Heart Center
City
Munchen
Country
Germany
Facility Name
Klinikum Nürnberg Süd
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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